UNITED NATIONS POPULATION INFORMATION NETWORK (POPIN)UN Population Division, Department of Economic and Social Affairs,with support from the UN Population Fund (UNFPA)

OCs Provide Emergency Contraception Option

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Network, Vol. 16, No. 4, Summer 1996
Oral Contraceptives
Copyright 1996, Family Health International
OCs Provide Emergency Contraception Option
Although not as effective as a regular method, OCs used after sex may
achieve contraception.
Women can prevent pregnancy even after unprotected sex by
using a readily available contraceptive method: Certain types of oral
contraceptives, when used as directed in high doses after unprotected
intercourse, are safe and 75 percent effective in preventing
pregnancy.1/
Although not as effective as a regular method, this
"emergency contraception" can prevent unwanted pregnancy among women
who have been sexually assaulted, experienced a contraceptive
failure, forgotten to use a regular contraceptive method or used it
incorrectly. Emergency contraception can protect them from resorting
to an unsafe abortion -- which kills up to 70,000 women in developing
countries every year2/ -- and it may prevent life-threatening
complications of pregnancy among women who are too young or too old
to bear a child safely.
"Emergency contraception should be emphasized as an option
in family planning services," says Dr. Roberto Rivera, FHI's
corporate director for international medical affairs. "It has an
important role as a backup method, particularly for the use of
barrier methods, and it should be provided simultaneously with them."
FHI considers the use of barrier methods with emergency contraception
as a backup to be a form of dual method use.
Oral contraceptives used for emergency contraception do not
cause abortion because they act before pregnancy begins. These
emergency contraceptive pills (ECPs) are thought to alter the uterine
lining, or endometrium, thus preventing implantation.3/ In some
cases, they may also interfere with ovulation or fertilization or
with the luteal phase. Using the pill on an emergency basis is safe,
even for many women who should not use oral contraceptives routinely.
Combined oral contraceptives taken at a dose of at least 100
micrograms (mg) ethinyl estradiol and 0.5 milligrams (mg)
levonorgestrel can be used for emergency contraception if taken
within 72 hours of unprotected intercourse and repeated 12 hours
later, as can doses of progestin-only pills totaling 0.75 mg
levonorgestrel if used within 48 hours and repeated 12 hours later.
In June, an advisory panel to the U.S. Food and Drug
Administration (FDA) concluded unanimously that certain oral
contraceptives approved for daily use are also safe and effective as
emergency contraceptive pills. The panel said the following dosages
of six brands were known to work: two tablets per dose of Wyeth's
Ovral or four tablets of Wyeth's Nordette, Lo/Ovral or Triphasil
(yellow pills only) brands, or four tablets of Berlex Laboratories'
Levlen or Tri-Levlen (yellow pills only) brands.
Emergency contraception can be achieved in other ways: Within
72 hours by using an antiprogestin (a single dose of 600 mg
mifepristone) or by inserting a copper-bearing intrauterine device
(IUD) within five days.
Bellagio consensus
Despite the safety and effectiveness of emergency
contraceptive pills, many providers are hesitant to offer them. At
a 1995 international conference on emergency contraception held in
Bellagio, Italy, experts from FHI, World Health Organization (WHO)
and other organizations outlined three main reasons why emergency
contraception is not widely available: women and providers are
uninformed about it, few products are marketed for it, and many
health programs do not offer them.4/
"Women everywhere should have access to these safe and
effective ways to prevent unwanted pregnancy," the Bellagio consensus
statement reads. "We must make access to emergency contraception a
reality."
Many women's health advocates agree. Information on emergency
contraception "is information every woman should have," says Judy
Norsigian of the Boston Women's Health Book Collective, which
publishes Our Bodies, Ourselves, a popular health manual for women.
Enthusiasm for emergency contraception is growing as
international agencies, researchers and providers see its usefulness.
"We already have the supplies for the method," says Dr. Charlotte
Ellertson, a program associate at the Population Council in New York.
"All it takes now is information. With emergency contraception, the
information is the method. We just require a new mindset."
While some health-care workers eagerly offer emergency
contraception, others have reasons for not providing it. A 1994
survey by the International Planned Parenthood Federation (IPPF)
found that many providers are reluctant to offer emergency
contraception because they are afraid it will be linked with
abortion, their staffs have no training to offer it, women have not
requested the service, and other reasons.5/
Other providers have expressed concern that access to
emergency contraception may make it less likely that some women could
refuse unwanted sexual intercourse, or that women will substitute the
method for regular contraception, thus exposing themselves to a
greater risk of unwanted pregnancy and sexually transmitted diseases.
Dr. Ellertson points out that women are unlikely to use
emergency contraceptive pills excessively. "The reason that women
would not use emergency contraceptive pills as an ongoing method is
that ECPs are less effective than other methods," she says. "ECPs
also have some unpleasant side effects that we think would dissuade
women from using it over and over again." Nausea, for example, is
common among users. Studies are under way to find out how women use
emergency contraception, she says.
These questions need to be addressed, but they should not
keep providers from offering emergency contraception to women who
need it, experts agree. "It is important not to deny women this
method," says Dr. Pramilla Senanayake, IPPF assistant secretary
general. Provider education is of prime importance, she says.
Emergency contraception "should be built into the normal educational
program for physicians, nurses, midwives and health-care providers."
Communicating with providers, policy-makers and women is a
crucial step in changing attitudes, according to an FHI study.6/
Communication can increase access, the authors say, by "strengthening
providers' knowledge of emergency contraception, increasing women's
awareness of its availability and where to obtain it, and overcoming
political obstacles."
Women who seek emergency contraception are often embarrassed
and frightened: They may be adolescents who have had their first
sexual contact, or women who have been sexually assaulted.
Because of these special circumstances, providers' attitudes
are very important in counseling potential users, according to
guidelines developed by Pathfinder International.7/ "Women in need
of emergency contraception are facing a serious personal crisis," the
guidelines read. "Make them feel confident that you are prepared to
help. Avoid prolonged counseling that might make the woman
uncomfortable."
The best counseling is nonjudgmental and includes information
about the efficacy, advantages, disadvantages, side effects and other
characteristics of emergency contraceptive pills. If appropriate,
counselors should also present options for contraception following
the use of emergency contraceptive pills, the guidelines say.
Clarifying guidelines
One reason more women do not use emergency contraceptive
pills is that there is confusion about what they are and how they
should be used.
Because they are commonly called "morning-after pills," some
women and providers mistakenly believe that the pills cannot be taken
later than the next morning or must be taken within a few hours after
intercourse. Others confuse emergency contraception with RU 486
(mifepristone), which can be used for emergency contraception but is
better known as a way of inducing abortion.
Combined oral contraceptive pills used postcoitally are the
same ones used as a regular contraceptive method, but taken in higher
doses of two or four tablets. Although the hormone doses in COCs when
used for emergency contraception are relatively high, they are
short-lived and can be used safely, even by women with cardiovascular
problems. According to WHO, the only absolute contraindication for
emergency oral contraceptive use is pregnancy.8/ If a woman is
already pregnant, she should not use emergency contraception. But if
a pregnant woman mistakenly takes the pills, there is no evidence
that they will harm the fetus.9/
Emergency contraceptive pills have been used for decades, but
guidelines for their use are inconsistent, says Dr. Linda Potter, an
FHI public health scientist. Dr. Potter and Tara Nutley, an FHI
program officer, have recently completed a comparison of ECP
guidelines used by eight organizations and researchers. Suggested
contraindications, drug interactions and other issues varied
dramatically.
Improving availability
Emergency contraceptive pills are safe and effective, but
they are not always convenient. Up to 50 percent of women who use
COCs for emergency contraception have nausea, and many of those women
vomit, potentially reducing the effectiveness of the pills.10/ In
addition, the short time limit for initiating ECP may discourage
women who must travel long distances to clinics or are unable to
reach them soon enough to receive pills. For example, many clinics
close on weekends, when emergency contraception is most often needed.
Several international studies are examining how to make
emergency contraceptive methods more available and useful to a wide
variety of women. For example, the South-to-South Cooperation in
Reproductive Health is comparing vaginal delivery of emergency
contraceptive pills with oral use, in a trial involving 600 women in
six countries.
So far, the two delivery methods seem to be equally effective
at preventing pregnancy, says Dr. Josue Garza-Flores, director of the
Mexico City-based Center for Assistance in Human Reproduction and a
researcher on the study.
But vaginal delivery doesn't seem to reduce nausea and
vomiting, he says. Still, because vaginal delivery prevents vomiting
of the pills themselves, it may prevent having to repeat a dose after
vomiting.
WHO is also looking for a way to reduce side effects in a
trial involving 2,200 women in 15 countries, says Dr. Paul Van Look,
associate director of WHO's Special Programme of Research,
Development and Research Training in Human Reproduction.
Dr. Fabienne Grou of the University of Montreal is examining
whether combined oral contraceptives are effective as emergency
contraception if initiated later than 72 hours after unprotected sex.
"If it works for only 40 or 50 percent of women, that would
be good" for those who have no other choice, Dr. Grou says. She has
found one difficulty in recruiting for the study: Women in Quebec
receive education about emergency contraception in school, and few
request it beyond 72 hours.
Dr. Ellertson of the Population Council is planning a similar
study, which will test the effectiveness of different regimens, such
as using other progestins, extending the 72-hour time limit or giving
one dose of hormones instead of two.
Limited approval
So far, few products have been marketed or labeled for
emergency contraception. In many countries, women or providers obtain
the needed pills by simply using a portion of pills from a monthly
packet of combined oral contraceptives.
In the United States, the June action by the FDA's
Reproductive Health Drugs Advisory Committee paves the way for
possible labeling of combined oral contraceptives for emergency use.
However, no pharmaceutical company has formally requested FDA
approval for marketing pills specifically for emergency
contraception.
"There is probably enough information in the published
literature to approve that use, if we should get an application [from
a drug company]," says Dr. Philip Corfman, an FDA medical officer.
The FDA can not approve relabling of drugs for new uses without an
application.
In other countries, emergency contraceptive pills have been
approved, and they have been packaged and labeled differently from
monthly cycles of oral contraceptives to make their use clear.
Berlin-based Schering sells two products -- PC4 and Tetragynon -- for
emergency contraception, primarily in Western Europe. Each packet
includes a user information leaflet and four pills containing
levonorgestrel and ethinyl estradiol.
Schering believes ECPs should be offered by prescription
only, says Lutz Schaffran, Schering's head of international family
planning. For that reason, the pharmaceutical company does not sell
ECPs in Asia and Latin America, where oral contraceptives are
typically bought in pharmacies without prescription.
In spite of these restrictions, emergency contraceptive pills
are becoming more widely available. For example, Schering is selling
the pills to African governments that request them because in Africa,
unlike Latin America and Asia, clinics and medical professionals are
more likely to provide the pills, Schaffran says. Zaire requested the
first shipment, which will primarily be used in refugee camps, he
says.
The Consortium for Emergency Contraception, a group of seven
organizations, plans to work with industry to produce an inexpensive
emergency contraceptive product. It will help introduce the product
in up to 15 developing countries over the next five years.
The first model introduction will begin in Kenya soon. Model
service delivery guidelines and other materials will be field tested
in Kenya and three other countries. "The thing that has surprised us
the most is the extrodinary level of interest in these methods and
the relative lack of controversy," says Dr. Sharon L. Camp, the
consortium's acting coordinator.
"Many health-care providers see this as an important addition
to the range of choices they have to give women who want control over
childbearing," she says. "It is a method that could reduce the need
for abortion, and in Kenya, illegal abortion is a very serious health
problem."
Vietnam and Latin America
In Vietnam, health-care providers rarely offer emergency
contraception. A 1995 Population Council survey in Ho Chi Minh City
found that providers knew little about emergency contraceptive pills,
says Dr. Nguyen thi Nhu Ngoc, vice-director of Hungvuong Hospital and
a principal investigator on the study.
But Vietnam has been moving to broaden its contraceptive
choices -- once limited primarily to IUDs and tubal ligation -- to
include oral contraceptive pills. At a recent meeting of 300
Vietnamese providers, Dr. Nguyen says, many showed an interest in
bringing emergency contraception to their practices. Before doing so,
they must learn how to provide the method correctly, she says.
Pathfinder International is beginning this type of education
in Hanoi. This year, Pathfinder will provide training on emergency
contraceptive pills to 300 pharmacists, the health-care workers who
provide the bulk of oral contraceptives in Vietnam. The organization
will also produce client instructions, says Cathy Solter, a
Pathfinder medical services associate.
In most of Latin America, emergency contraception is
virtually unavailable, primarily because it is confused with
abortion, says Dr. Garza-Flores of Mexico City. Abortion is
restricted and stigmatized in Latin America.
For the past 18 months, Dr. Garza-Flores has been offering
emergency contraception at his clinic, and about 80 women, mostly
young, have requested it. In order to reach more women, Dr.
Garza-Flores is working with Mexico's national human rights
commission, which helps victims of sexual assault. He is hoping to
convince the commission to make information on emergency
contraception available to women, he says.
Brazil is also moving toward making emergency contraception
accessible. In March, the Ministry of Health and the Population
Council organized a nationwide meeting to follow up on last year's
Bellagio conference. Out of the meeting came policy recommendations
that will be distributed throughout the country, says Dr. Juan Díaz,
a Population Council senior associate in Brazil.
The group recommended that emergency contraception be
included in the Ministry's technical norms; that combined oral
contraceptives be the emergency method of choice in Brazil; and that
access to emergency contraception be promoted.12/ According to the
group, "All women of reproductive age at risk of developing an
unwanted pregnancy should have access to emergency contraception."
-- Carol Lynn Blaney
Editor's note: Carol Lynn Blaney, a former Network staff
writer, is a free-lance science writer who lives in San Jose, CA,
USA.
Footnotes
1. Trussell J, Ellertson C, Stewart F. The effectiveness of
the Yuzpe regimen of emergency contraception. Fam Plann Perspect
1996;28(2):58-64, 87.
2. World Health Organization. Abortion: A Tabulation of
Available Data on the Frequency and Mortality of Unsafe Abortion, 2nd
ed. Geneva: World Health Organization, 1994.
3. Grou F, Rodrigues I. The morning-after pill -- How long
after? Am J Obstet Gynecol 1994;171(6):1529-34.
4. Consensus statement on emergency contraception.
Contraception 1995;52:211-13.
5. Senanayake P. Emergency contraception: The International
Planned Parenthood Federation's experience. Int Fam Plann Perspect
1996;22(2):69-70.
6. Robinson ET, Metcalf-Whittaker M, Rivera R. Introducing
emergency contraceptive services: Communications strategies and the
role of women's health advocates. Int Fam Plann Perspect
1996;22(2):71-75, 80.
7. Pathfinder International. Emergency contraceptive pills
(ECPs) service delivery guidelines. Unpublished paper.
8. World Health Organization. Improving Access to Quality
Care in Family Planning: Medical Eligibility Criteria for
Contraceptive Use. (Geneva: World Health Organization, 1996) 32.
9. Webb A. How safe is the Yuzpe method of emergency
contraception? Fertil Control Rev 1995;4(2):16-18.
10. Trussell.
11. Population Council, Brazilian Ministry of Health. Final
Report of the 1st Brazilian Workshop on Emergency Contraception: A
Technical Advisory Group for Its Use in Brazil. Brasilia: Brazilian
Ministry of Health, 1996.
Copyright 1996, Family Health International. Any part of this text
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